Who else makes this device?

Clinical Chemistry › Test SystemsComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Advanced Instruments Osmolality Linearity Set – 5 Level – 5ml Ampule – Pkg 10

The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range…

Registry build 21.09.26

The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method.

1manufacturer

1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JMZ
Manufacturer	City	Province	Registered as	Device types
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61

Record

Regulatory record for Advanced Instruments Osmolality Linearity Set – 5 Level – 5mL Ampule – Pkg 10
Listed by	Advanced Instruments, LLC, United States
FDA product code	JMZ
Device type	Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Device class	Class 1
Regulation	21 CFR 862.1540
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2020-09-21
Record revised	2026-06-19 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for Advanced Instruments Osmolality Linearity Set – 5 Level – 5mL Ampule – Pkg 10
Catalogue number	Size	Status
3LA028		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Advanced Instruments Clinitrol 290 Reference Solution – 2mL Ampule – Pkg 10	Advanced Instruments, LLC	2
Advanced Instruments 500 mOsm Calibration Standard – 5mL Ampule – Pkg 10	Advanced Instruments, LLC	2
Advanced Instruments 100 mOsm Calibration Standard – 110 mL Bottle	Advanced Instruments, LLC	2
Advanced Instruments 1500 mOsm Calibration Standard – 110 mL Bottle	Advanced Instruments, LLC	2
Advanced Instruments 900 mOsm Calibration Standard – 110 mL Bottle	Advanced Instruments, LLC	2
Advanced Instruments Heat Transfer Fluid	Advanced Instruments, LLC	1
Advanced Instruments 50 mOsm Calibration Standard – 2mL Ampule – Pkg 10	Advanced Instruments, LLC	1
Precision Systems 0 mOsm Osmometry Standard	Precision Systems, Inc.	1
Advanced Instruments 2000 mOsm Calibration Standard – 5mL Ampule – Pkg 10	Advanced Instruments, LLC	1
Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle	Precision Systems, Inc.	1
Precision Systems 400 mOsm Osmometry Standard	Precision Systems, Inc.	1
Precision Systems 600 mOsm Osmometry Standard	Precision Systems, Inc.	1

Showing 12 of 43. All products under Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.